[Federal Register Volume 62, Number 229 (Friday, November 28, 1997)]
[Notices]
[Pages 63350-63351]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-31149]


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 DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food And Drug Administration
[Docket No. 97F-0468]


Ciba Specialty Chemicals Corp.; Filing of Food Additive Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that Ciba 
Specialty Chemicals Corp., has filed a petition proposing that the food 
additive regulations be amended to provide for the safe use of 
tris(2,4-di-tert-butylphenyl)phosphite by removing the restrictions on 
the temperature of use in low density polyethylene films of thickness 
greater than 0.051 millimeter (mm) (0.002 inch (in)), provided that the 
film does not contain a total of tris(2,4-di-tert-butylphenyl)phosphite 
in excess of 0.062 milligram (mg) per in2 of the food-
contact surface.

DATES: Written comments on petitioner's environmental assessment by 
December 29, 1997.

ADDRESSES: Submit written comments to the Dockets Management Branch

[[Page 63351]]

(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Vir D. Anand, Center for Food Safety 
and Applied Nutrition (HFS-216),  Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-418-3081.

SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic 
Act (sec. 409(b)(5) (21 U.S.C. 348(b)(5))), notice is given that a food 
additive petition (FAP 8B4563) has been filed by Ciba Specialty 
Chemicals Corp., c/o Keller and Heckman, 1001 G St. NW., suite 500 
West, Washington, DC 20001. The petition proposes to amend the food 
additive regulations in Sec. 178.2010 Antioxidants and/or stabilizers 
for polymers (21 CFR 178.2010) to provide for the safe use of tris(2,4-
di-tert-butylphenyl)phosphite by removing the restriction on the 
temperature of use in low density polyethylene films of thickness 
greater than 0.051 mm (0.002 in), provided that the film does not 
contain a total of tris(2,4-di-tert-butylphenyl)phosphite in excess of 
0.062 mg per in2 of the food-contact surface.
    The agency has determined under 21 CFR 25.32(i) that this action is 
of the type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

    Dated: November 4, 1997.
Alan M. Rulis,
Director, Office of Premarket Approval, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 97-31149 Filed 11-26-97; 8:45 am]
BILLING CODE 4160-01-F